复方茵陈颗粒质量标准的建立  

Establishment of Quality Standard for Fufang Yinchen Granules

作　　者：吴琼[1] 王姝 王琳琳[1] 胡北[1] 贾辉[1] 王常丽[1] 马宏达[1] 

机构地区：[1]沈阳军区总医院药剂科,辽宁沈阳110016 [2]辽宁省食品药品监督管理局行政服务中心

出　　处：《中国药师》2015年第7期1229-1231,共3页China Pharmacist

摘　　要：目的：建立复方菌陈颗粒的质量标准。方法：采用薄层色谱法，对该品种中的大黄、黄芩进行专属性鉴别；采用高效液相色谱法对处方中黄芩的有效成分黄芩苷进行含量测定。色谱柱为Welehrom C18（200mm×4．6mm，5μm），流动相为甲醇-水-磷酸（40：60：0．2），流速为1．0ml·min^-1，检测波长为280nm，柱温为室温，进样量为20μl。结果：大黄、黄芩的TLC特征斑点清晰，分离度好，阴性对照无干扰。黄芩苷在1—49μg·ml^-1的浓度范围内呈良好线性关系（r=0．9997），平均加样回收率为98．95％，RSD=2．52％（n=6）。结论：所建立的方法简单、准确、重复性良好，可用于复方菌陈颗粒质量控制。Objective： To establish the quality standard for Fufang Yinchen granules. Methods： Rheum palmatum L. and Scutellaria baicalensis Georgi were identified by TLC. An HPLC method was adopted on a Welchrom C18 column（200 mm × 4.6 mm, 5 μm） with methanol-water-phosphoric acid（40： 60： 0.2） as the mobile phase, the flow rate was 1.0 ml ·min^-1, the detection wave- length was 280 nm, the column temperature was ambient and the injection voulme was 20 μl. Results： The TLC spots were clear with good resolution and without interference from the negative samples. There was a good linearity within the range of 1-49 μg · ml ^- 1 （ r = 0.999 7）. The average recovery of baicalin was 98.95% with RSD of 2.52% （n =6）. Conclusion： The method is simple,aceurate and reproducible, which can be used in the quality control of Fufang Yinchen granules.

关 键 词：复方茵陈颗粒 黄芩苷 高效液相色谱法 薄层色谱法 质量标准 

分 类 号：TQ460.72[医药卫生—药物分析学]